MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number SN60AT

Device Problems Malposition of Device (2616); Material Split, Cut or Torn (4008)

Patient Problem No Code Available (3191)

Event Date 09/11/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.Based on the results from the product and batch history record, the product met release criteria.Root cause cannot be identified at this time.There have been no other complaints reported in the lot number.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported upon implanting an intraocular lens (iol), a crack was noted on the haptic.The lens was centered and stable so the surgeon left the lens implanted.During a follow up visit, it was found the haptic was completely torn and was directly over the implanted lens.The lens was removed during a secondary procedure.Additional information was requested.

Manufacturer Narrative

The product was returned for analysis and damage was observed to the lens.The report states the use of "company iii d" cartridge and "avisc 1%" as viscoelastic , which are not qualified to be used with the associated lens model reported model device.The provided photo shows iol segments loose in an opened pouch.One haptic appears to be broken/torn.Optic appears to be torn/split/cut dividing the iol in two (2) segments.Additional observations were as follows: iol returned in two (2) segments inside a zip lock bag.One segment was adhered to gauze tape.A significant amount of solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and is returned.The optic is torn/split-cut dividing the iol in two(2) and scratched/marked-rejectable.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow the instruction of qualified iol delivery system product combinations and alternative viscoelastic, as the complainant states the use of an unqualified combination.The use of nonqualified combinations may result in delivery issues and/or damage.All product and batch history records are quality reviewed prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• MDR Report Key: 9188277
• MDR Text Key: 162662039
• Report Number: 9612169-2019-00315
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: SN60AT
• Device Catalogue Number: SN60AT.170
• Device Lot Number: 21207079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 01/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH D CARTRIDGE; MONARCH III D CARTRIDGE; MONARCH III HANDPIECE; MONARCH III IOL DELIVERY SYST; OVD: AVISC 1%
• Patient Outcome(s): Required Intervention